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Amsino International, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K220230AMSure Enteral Feeding PumpNovember 10, 2022
K220267AMSafe NeuFlo Needleless ConnectorOctober 7, 2022
K213522AMSafe Pre-Filled Normal Saline Flush SyringeMarch 22, 2022
K200051PUGGLE Enteral Feeding Pump and Feeding SetSeptember 25, 2020
K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeJuly 12, 2019
K181445AMSure Hydrophilic Intermittent CatheterOctober 1, 2018
K181423AMSure Sterile Water, and Sterile Normal Saline for Wound FlushSeptember 7, 2018
K173665AMSafe Sure-Lok Needle-Free ConnectorSeptember 5, 2018
K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterSeptember 4, 2018
K171857AMSure® Enteral Feeding Syringe with ENFit TipMarch 30, 2018
K101958AMSINO I.V. ADMINISTRATION AND EXTENSION SETSSeptember 29, 2010
K101824AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETERSeptember 13, 2010
K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSMarch 10, 2010
K091306AMSURE PVC INTERMITTENT CATHETERAugust 21, 2009
K091699AMSURE HYDROPHILIC LATEX FOLEY CATHETERAugust 10, 2009
K082831AMSELF CLOSED CATHETERIZATION SYSTEMOctober 23, 2008
K070411AMSURE NEBULIZEROctober 1, 2007
K061039AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLEJune 29, 2006
K050785AMSINO ENDOTRACHEAL TUBEJuly 15, 2005
K051059AMSURE 100% SILICONE FOLEY CATHETERJune 28, 2005